Senior Engineer, NPD-Quality

Senior quality engineer role supporting new product development for cardiac surgical technologies. The position involves managing design control documentation, risk management processes, and cross-functional collaboration to ensure regulatory compliance and product safety throughout the development lifecycle.

Responsibilities

• Create and maintain design control documentation and risk management files throughout product development
• Collaborate with R&D, manufacturing, and clinical teams on design verification, validation, and product launch activities
• Investigate product quality and compliance issues; analyze findings and develop corrective action recommendations
• Optimize manufacturing and R&D processes using engineering methodologies to improve efficiency and reduce risk
• Train and supervise technicians on testing procedures and provide guidance to junior staff

Requirements

• Bachelor's degree in engineering or science with 4+ years industry experience
• Master's degree in engineering or science with 3+ years industry experience (alternative)
• Ph.D. in engineering or science with industry experience (alternative)
• FDA medical device regulations knowledge
• Proficiency with MS Office Suite and project management tools
• Statistical analysis and problem-solving skills
• Leadership ability and cross-functional team collaboration experience

Compensation: $108,000–$153,000 base (California)